da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED MALIGNANT HYSTERECTOMY SURGICAL PROCEDURE, A BLACK VALVE WAS BROKEN ON THE THIRD PORT CANNULA AND FELL INTO THE PATIENT. THE VALVE WAS THOUGHT TO BE FROM THE UNIVERSAL SEAL, BUT THE CUSTOMER CONTINUED TO USE THE PRODUCT WITHOUT REPLACEMENT. THE OPERATION WAS TERMINATED. THERE WAS NO BLEEDING DUE TO THE ISSUE NOR ANY TISSUE/VASCULAR DAMAGE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER CLARIFIED THAT THE FRAGMENTS WERE RETRIEVED WITH A LAPAROSCOPIC INSTRUMENT, AND THEY CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED USING THE ENDOSCOPE. THERE WAS NO ADDITIONAL PROCEDURE REQUIRED, THERE WAS A POST-OPERATIVE TEST DONE. THE CUSTOMER COMPLETED THE PROCEDURE ROBOTICALLY. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL FOR ANY COMPLICATIONS. THE ACCESSORY IS NOT AVAILABLE FOR RETURN AND THE FRAGMENT WAS DISCARDED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT AFTER A DA VINCI-ASSISTED RADICAL PROSTATECTOMY WITH LYMPHADENECTOMY PROCEDURE, THE PATIENT HAD A POST-OPERATIVE PULMONARY EMBOLISM; THE SURGEON OF THE PROCEDURE REPORTED THAT THE PATIENT ALMOST DIED. THE PROCEDURE WAS FOUR HOURS LONG AND WAS COMPLETED WITHOUT COMPLICATIONS. THE SURGEON SAID THE EMBOLISM WAS NOT RELATED TO THE USE OF THE DA VINCI SINGLE PORT (SP) SYSTEM. THE SURGEON WAS BEING PROCTORED THIS PROCEDURE. THE SURGEON REPORTED THAT THE PATIENT RECEIVED NORMAL THROMBOSIS PROPHYLAXIS WITH TIGHT SOCKS AND LOW MOLECULAR HEPARIN POSTOPERATIVELY FROM OR-DAY AND ONWARDS (HOSPITAL STANDARD). THE PATIENT EXPERIENCED A THROMBOEMBOLIC PULMONAL EMBOLISM CENTRALLY WITH PAIN AND DIFFICULTIES TO BREATH WITHOUT A FULMINANT EVENT TWO DAYS AFTER SURGERY. THE PATIENT EXPERIENCED DIFFICULTIES TO RECOVER APPROPRIATELY AFTER SURGERY AND DID NOT FEEL WELL. THE EMBOLISM WAS CONFIRMED WITH A CT-SCAN OF THE THORAX AND ELEVATED D-DIMER SCORES. THE PATIENT RECEIVED CONSERVATIVE TREATMENT WITH HEPARIN ON A THERAPEUTIC LEVEL. THE PATIENT DEVELOPED A RETRO-VESICAL HEMATOMA AND INSUFFICIENCY OF THE ANASTOMOSIS WITH SEVERAL TRANSFUSIONS. THE PATIENT WAS PLACED IN THE INTENSIVE CARE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DESCRIPTION OF EVENT ON (B)(6) 2024, THE PATIENT UNDERWENT A ROBOTIC-ASSISTED PARTIAL HYSTERECTOMY UTILIZING THE DA VINCI ROBOTIC SURGICAL SYSTEM AT (B)(6) MEDICAL CENTER IN (B)(6). FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED SEVERE AND LIFE-THREATENING POSTOPERATIVE COMPLICATIONS, INCLUDING: SEPSIS, MULTIPLE ORGAN DAMAGE, SEVERE INFECTION LEADING CHRONIC LONG-TERM INFECTIONS, PROLONGED HOSPITALIZATION, ADDITIONAL SURGEONS, COVERING 4 MAJOR BODY SYSTEMS, PERMANENT PHYSICAL IMPAIRMENT AND SEVERE EMOTIONAL MEDICAL ANXIETY. THE SEVERITY AND PROGRESSION OF THESE COMPLICATIONS RAISES SIGNIFICANT CONCERNS REGARDING POTENTIAL DEVICE-RELATED INJURY, DELAYED RECOGNITION OF INTRAOPERATIVE INJURY, OR POSSIBLE MALFUNCTION OR LIMITATIONS ASSOCIATED WITH THE ROBOTIC SURGICAL SYSTEM. DEVICE-RELATED CONCERNS BASED ON MEDICAL RECORDS AND POSTOPERATIVE CLINICAL COURSE, THE FOLLOWING CONCERNS REQUIRE INVESTIGATION: 1. POSSIBLE DEVICE MALFUNCTION THERE IS CONCERN THAT THE DA VINCI ROBOTIC SURGICAL SYSTEM MAY HAVE EXPERIENCED MALFUNCTION, CALIBRATION ERROR, OR MECHANICAL OR SOFTWARE-RELATED PERFORMANCE ISSUES DURING THE PROCEDURE. 2. INADEQUATE VISUALIZATION THERE IS CONCERN THAT VISUALIZATION PRO

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE CUSTOMER REPORTED THEY HAD ISSUES WITH THE UNIVERSAL SEAL. THE CUSTOMER REPORTED ONE OF THE UNIVERSAL SEALS CAME APART AND A PIECE OF THE RUBBER FELL OFF INTO THE ABDOMEN OF THE PATIENT. THE PIECE WAS RECOVERED DURING THE SAME PROCEDURE. ADDITIONALLY, DURING THE SAME PROCEDURE, ONE OF THE OTHER UNIVERSAL SEALS HAD THE PLASTIC INSUFFLATION PORT BREAK OFF. THERE WAS NO MENTION OF ANY FRAGMENT FALLING INSIDE THE PATIENT WITH THE SECOND UNIVERSAL SEAL. THE CUSTOMER WAS NOT ABLE TO RECORD THE LOT NUMBER OF THE SEALS USED BUT THEY WILL BE SENDING THE DAMAGED ONES BACK FOR INVESTIGATION. BOTH SEALS WERE REMOVED AND REPLACED AND THEY WERE ABLE TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SURGEON WAS ABLE TO REMOVE ALL FRAGMENTS PER THE STAFF REPORT. THE REPORTER STATED THERE WAS NO ADDITIONAL SURGICAL PROCEDURE REQUIRED TO REMOVE THE FRAGMENT. THERE WAS NO POST-OPERATIVE TEST LIKE AN X-RAY OR ULTRASOUND TO CHECK FOR REMAINING FRAGMENTS. THE PROCEDURE WAS COMPLETED ROBOTICALLY

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE CAMERA WAS PLUGGED IN AND THE 'CAMERA BUMP' WARNING APPEARED. THE CASE WAS CANCELLED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING REVIEW OF A LITERATURE ARTICLE THAT ADDRESSES THE POSSIBLE BENEFITS OF NERVE MONITORING DURING DA VINCI-ASSISTED RADICAL PROSTATECTOMY SURGICAL PROCEDURES, THE FOLLOWING COMPLICATIONS WERE MENTIONED: THE STUDY WITH 100 PATIENTS ENROLLED, EXAMINED THE BENEFITS OF USING A NERVE MONITORING SYSTEM DURING ROBOT-ASSISTED RADICAL PROSTATECTOMY (THE INTERVENTION ARM) VERSUS THE STANDARD OF CARE (THE CONTROL GROUP). AVAILABLE FOR FINAL ANALYSIS AT 12 MONTHS 82 PATIENTS REMAINED IN THE STUDY, 41 PATIENTS IN EACH GROUP. THERE WERE EIGHT CLAVIEN-DINDO GRADE GREATER THAN OR EQUAL TO III COMPLICATIONS, ONE CASE OF SEVERE MESENTERIC BLEEDING, ONE RECTAL LESION, AND ONE SPHINCTERIC LESION, ALL IN THE CONTROL GROUP. THERE WERE FIVE CASES OF ANASTOMOSIS LEAKAGE, TWO IN THE INTERVENTION GROUP AND THREE IN THE CONTROL GROUP. WE DETECTED NERVE SIGNALS DURING MONITORING IN ALL PARTICIPANTS IN THE INTERVENTION GROUP BEFORE THE REMOVAL OF THE PROSTATE. THERE WERE NO STATISTICALLY SIGNIFICANT DIFFERENCES IN SURGICAL TIME OR BLOOD LOSS. THERE WAS NO REPORT IN THE ARTICLE THAT A DA VINCI DEVICE MALFUNCTIONED DURING THE PROCEDURES. INTUITIVE SURGICAL, INC. (ISI) ATTEMPTED FOLLOW-UP TO OBTAIN ADDITIONAL

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE SYNCHROSEAL ¿SCREW¿ CAME OFF. THE FRAGMENT WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETING AS PLANNED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO ISSUE. THE SCREW FELL INTO THE PATIENT¿S ANATOMY WHEN THE INSTRUMENT WAS BEING USED. THE INSTRUMENT DID NOT GRASP THE TISSUE. THE SURGEON BELIEVED THAT MANUFACTURING WAS THE CAUSE OF THE ISSUE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR HARD MATERIAL. THE SURGEON USED A LAPAROSCOPIC FORCEPS TO RETRIEVE THE FRAGMENT. NO ADDITIONAL SURGICAL PROCEDURE WAS PERFORMED TO REMOVE THE FRAGMENT. UPON VISUAL INSPECTION, THE SURGEON CONFIRMED THAT THERE WAS NO REMAINING FRAGMENT. NO POST-OPERATIVE TESTS WERE PERFORMED. THE SURGEON STATED THAT NO PATIENT INJURY. THE PATIENT DID NOT RETURN TO THE HOSPITAL DUE TO ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE INSTRUMENT AND THE FRAGMENT WILL BE RETURNED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PREPARING FOR A CRANIAL CASE, TURN ROBOT ON, AND NOT GETTING PAST THE EXCELSIUS GPS HOME SCREEN. TRIED RESTARTING AND POWER CYCLING, UNPLUGGING FOR MULTIPLE MINUTES. HAVE NOT BEEN ABLE TO GET PAST IT.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT THE ALL THE USERS PASSWORDS HAD EXPIRED AND THEY WERE UNABLE TO LOGIN TO THE MONARCH SYSTEM. THE PHYSICIAN ELECTED TO ABORT THE CASE AND RESCHEDULED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE USING THE EXCELSIUS GPS SYSTEM, THE CASE WAS ABORTED AND SCREWS WERE THEN PLACED BY HAND.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: TA LITERATURE ARTICLE WAS REVIEWED THAT DESCRIBED A COHORT STUDY OF 2225 PATIENTS THAT UNDERWENT ROBOT-ASSISTED SURGERY (RAS) IN GYNECOLOGICAL ONCOLOGY FROM JANUARY 2015 TO DECEMBER 2022. THE AIM OF THE STUDY WAS TO PROVIDE A COMPREHENSIVE DESCRIPTION OF PERIOPERATIVE MORBIDITY ASSOCIATED WITH RAS IN GYNECOLOGICAL ONCOLOGY TO ENHANCE PREOPERATIVE COUNSELING AND SUPPORT SHARED DECISION-MAKING. A GYNECOLOGICAL ONCOLOGIST PERFORMED THE SURGERY IN 98% OF THE CASES, AND 64% OF THESE SURGEONS WERE ALREADY EXPERIENCED IN RAS (>50 ROBOTIC PROCEDURES). THE DA VINCI SI SYSTEM WAS USED IN 524 CASES AND THE DA VINCI XI SYSTEM IN 1701 CASES. THE STUDY REPORTED 64 INTRAOPERATIVE COMPLICATIONS, WITH BOWEL INJURIES BEING THE MOST COMMON. TWO PATIENTS EXPERIENCED TROCAR LESIONS OF THE COLON REQUIRING CONVERSION TO LAPAROTOMY, WHILE THE OTHER BOWEL LESIONS (TYPICALLY SEROSAL TEARS OR THERMAL LESIONS) WERE HANDLED BY ROBOT-ASSISTED SUTURING. VASCULAR COMPLICATIONS OCCURRED IN 16 PATIENTS, INCLUDING ONE BLUNT LESION OF THE ABDOMINAL AORTA DURING ENTRY WITH A BLUNT-TIP TROCAR IN A VERY SLIM PATIENT, AND 1 LESION OF THE RIGHT EXTERNAL ILIAC VEIN FOLLOWING LYMPHADENECTOMY AFTER PELVIC IRRADIATION. BOTH C

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE HARMONIC ACE INSTRUMENT STOPPED WORKING. A PIECE OF THE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT. THE INSTRUMENT FRAGMENT WAS RETRIEVED DURIGN THE SAME PROCEDURE WHICH WAS COMPLETED ROBOTICALLY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A PATIENT WHO WAS ENROLLED IN A CLINICAL STUDY UNDERWENT A DA VINCI-ASSISTED NIPPLE SPARING MASTECTOMY. A 6MM SKIN BURN WAS FOUND ON THE RIGHT BREAST WITH A SMALL BLISTER, DURING INTERNAL DISSECTION. THE BURN WAS TREATED WITH TOPICAL (BACITRACIN) TWICE DAILY. THERE WAS NO DEVICE MALFUNCTION OCCURRED THAT COULD HAVE CONTRIBUTED TO THE BURN AND THE SURGEON THOUGHT THE BURN WAS CAUSED BY DISSECTION TOO CLOSE TO THE DERMIS DURING INTERNAL DISSECTION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A DBS CASE SET UP A CAMERA HARDWARE MALFUNCTION, WARNING DISPLAYED ONCE THE CAMERA WAS PLUGGED IN. THE JAR ALARM INDICATOR LIGHT WAS ALSO ILLUMINATED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND POST OP CT SCAN CONFIRMED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND POST OP CT SCAN SHOWS MULTIPLE MEDIAL BREACHES.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY, THE ENTIRE TIP FROM THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT THE ENTIRE PIECE WAS RETRIEVED AND ACCOUNTED FOR DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED ROBOTICALLY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) TIPS COVER ACCESSORIES FELL OFF THE INSTRUMENTS INSIDE THE PATIENT. THE SURGEON RETRIEVED THE MCS TIP COVER ACCESSORIES AND USED A MONOPOLAR CAUTERY INSTRUMENT WITH A HOOK TIP TO COMPLETE THE PROCEDURE. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT AND MCS TIP COVER ACCESSORY WERE INSPECTED PRIOR TO USE AND NO DAMAGE WAS OBSERVED. THE MCS TIP COVER WAS RETRIEVED WITH A GRASPER. THE SURGEON DID NOT NOTICE ANY ISSUES WITH THE FUNCTIONALITY OF THE MCS INSTRUMENT DURING THE SURGICAL PROCEDURE. THE MCS TIP COVER ACCESSORY WAS PROPERLY INSTALLED DURING THE SURGICAL PROCEDURE AND NO PART OF THE ORANGE SURFACE WAS VISIBLE AFTER THE MCS TIP COVER ACCESSORY WAS INSTALLED. THE MCS TIP COVER ACCESSORY WAS NOT INSTALLED BEYOND THE ORANGE SURFACE. THE INSTALLATION TOOL WAS USED. THERE WAS NO DIFFICULTY IN REMOVING THE INSTRUMENT AND MCS TIP COVER ACCESSORY. THE INSTRUMENT WRIST WAS STRAIGHTENED UPON REMOVAL. THE PROCEDURE WAS ROBOTICALLY COMPLETED. THE MCS TIP COVER ACCESSORY AND INSTRUMENT WERE NOT AVAILA

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED RIGHT PARTIAL NEPHRECTOMY PROCEDURE, THE PATIENT HAD A LOT OF BLEEDING. THE PROCEDURE WAS ABORTED AND CONVERTED TO OPEN SURGERY. DURING THE PROCEDURE, A THIRD-PARTY GOLD SCANLAN BULLDOG CLAMP WAS USED VIA A SEPARATE PORT SITE. THE USE OF THE SCANLAN BULLDOG CLAMP WAS A REQUIRED STEP FOR THE PROCEDURE, THIS WAS USED TO CLAMP THE RENAL ARTERY. THE SURGEON REPORTED THAT THE SCANLAN BULLDOG CLAMP DID NOT HAVE A STRONG ENOUGH GRIP TO CLAMP THE PATIENT'S STIFF RENAL ARTERY WHICH CAUSED A LOT OF BLEEDING. THE BLEEDING COULD NOT BE CONTROLLED, AND THE PROCEDURE WAS CONVERTED TO OPEN. THE PATIENT WAS REPORTED TO BE STABLE AND REMAINS HOSPITALIZED. THE SURGEON REPORTED THAT THERE WAS NOT AN ISSUE WITH THE SINGLE PORT PLATFORM BUT RATHER, WITH THE THIRD-PARTY INSTRUMENTATION CLAMPING PRESSURE.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY, THE ENTIRE TIP FROM THE HARMONIC ACE INSTRUMENT BROKE OFF AND FELL INSIDE THE PATIENT THE ENTIRE PIECE WAS RETRIEVED AND ACCOUNTED FOR DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW WAS CONDUCTED OF A LITERATURE ARTICLE COMPARING DA VINCI-ASSISTED ROBOTIC PARTIAL PANCREATODUODENECTOMY (RPD) WITH OPEN PARTIAL PANCREATODUODENECTOMY (OPD) SURGICAL PROCEDURES AT A HIGH-VOLUME PANCREATIC CENTER, HIGHLIGHTED FINDINGS OF A RANDOMISED CONTROLLED TRIAL (RCT) WITH TWO PARALLEL STUDY ARMS. THE STUDY INCLUDED 81 PATIENTS (41 ROBOTIC AND 40 OPEN) OVER A PERIOD OF APPROXIMATELY 1 1/2 YEARS AND COMPARED THE OUTCOMES OF THE RPD PATIENTS VERSUS THOSE OF THE OPD PATIENTS. DESCRIBED OUTCOMES INCLUDED POST-PANCREATECTOMY HEMORRHAGES (4 VERSUS 1), MAJOR BILIARY LEAKS (5 VERSUS 3), DELAYED GASTRIC EMPTYING (10 VERSUS 2), AND MAJOR CHYLE LEAKS (2 VERSUS 1). ALSO, IN THE RPD GROUP, 4 PATIENTS REQUIRED RE-OPERATION, 5 PATIENTS REQUIRED READMISSION, 15 PATIENTS REQUIRED NON-SURGICAL REINTERVENTION, 20 PATIENTS REQUIRED CT-GUIDED DRAIN PLACEMENT, 4 PATIENTS REQUIRED ANGIOGRAPHY, AND 7 PATIENTS REQUIRED UNSPECIFIED REINTERVENTION. BLOOD LOSS AND THE NUMBER OF PATIENTS WITH INTRAOPERATIVE BLOOD TRANSFUSIONS DID NOT DIFFER RELEVANTLY BETWEEN BOTH GROUPS. THE STUDY INDICATED THAT IN THE SETTING OF A VERY HIGH-VOLUME CENTER, BOTH RPD AND OPD CAN BE CONSIDERED SAFE TECHNIQUES. THERE

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, AFTER THE PATIENT WAS UNDER ANESTHESIA, A NON-RECOVERABLE FAULT 319 OCCURRED ON THE PATIENT SIDE MANIPULATOR (PSM) 1. THE CUSTOMER PERFORMED HARD POWER CYCLE OF THE SYSTEM, BUT THE SAME ISSUE PERSISTED. THE PROCEDURE WAS CONVERTED TO LAPAROSCOPIC SURGERY WITH NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE SYSTEM FUNCTIONALITY WAS CHECKED UPON POWERING ON, AND THE SYSTEM INITIALIZED WITHOUT ERROR. THE CUSTOMER IDENTIFIED THE ISSUE AFTER PORTS PLACEMENT. THERE WERE NO INTRA-OPERATIVE OR POST-OPERATIVE COMPLICATIONS IDENTIFIED. IT WAS UNKNOWN IF THE CONVERSION RESULTED IN INCREASING PORT SIZE INCISION OR ADDING ADDITIONAL PORTS.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC BYPASS (ROUX-EN-Y) SURGICAL PROCEDURE, THE CUSTOMER REPORTED AN ISSUE WITH THE VESSEL SEALER EXTEND (VSE). THE VSE FAILED AND RESULTED IN AN ABORT TO OPEN. THE INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) REVIEWED THE LOGS BUT FOUND NO RELATED ISSUE. THE CUSTOMER HAD NO ADDITIONAL DETAILS ABOUT THE ISSUE AS FAR AS THE ARM IT WAS INSTALLED IN, WHETHER THE VSE WAS USED IN THE E100/IESU, OR HOW EXACTLY THE VSE FAILED BUT THE CUSTOMER HAS INDICATED SOMETHING WAS WRONG AND WAS NOT GOING TO PERFORM SURGERY WITHOUT THE SYSTEM BEING CHECKED. THE PROCEDURE WAS CONVERTED TO OPEN SURGERY.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WIDMANN, R. F., WISCH, J. L., TRACEY, O. C., ZUCKER, C. P., FEDDEMA, T., MILLER, F., LINDEN, G. S., ERICKSON, M., & HEYER, J. H. (2024). ANALYSIS OF 5,070 CONSECUTIVE PEDICLE SCREWS PLACED UTILIZING ROBOTICALLY ASSISTED SURGICAL NAVIGATION IN 334 PATIENTS BY EXPERIENCED PEDIATRIC SPINE DEFORMITY SURGEONS: SURGICAL SAFETY AND EARLY PERIOPERATIVE COMPLICATIONS IN PEDIATRIC POSTERIOR SPINAL FUSION. SPINE DEFORMITY. HTTPS://DOI.ORG/10.1007/S43390-024-00854-7 PURPOSE: THIS STUDY EVALUATES THE INTRAOPERATIVE AND SHORT-TERM COMPLICATIONS ASSOCIATED WITH ROBOTICALLY ASSISTED PEDICLE SCREW PLA CEMENT IN PEDIATRIC POSTERIOR SPINAL FUSION (PSF) FROM THREE SURGEONS AT TWO DIFERENT INSTITUTIONS. METHODS: WE RETROSPECTIVELY REVIEWED 334 PEDIATRIC PATIENTS WHO UNDERWENT PSF WITH ROBOTIC-ASSISTED NAVIGATION AT 2 INSTITUTIONS OVER 3 YEARS (2020¿2022). FIVE THOUSAND SEVENTY ROBOTICALLY PLACED SCREWS WERE EVALUATED. DATA COLLECTION FOCUSED ON INTRAOPERATIVE AND EARLY POSTOPERATIVE COMPLICATIONS WITH MINIMUM 30-DAY FOLLOW-UP. PATIENTS UNDERGOING REVISION PROCEDURES WERE EXCLUDED. RESULTS: INTRAOPERATIVE COMPLICATIONS INCLUDED 1 DUROTOMY, 6 PATIENTS WITH NEUROMONITORING ALERTS NOT RELATED TO SCREW PLAC

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY, THE CASE WAS ABORTED AND THEN FREE HANDED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED, WITH SUBSEQUENT DURAL TEAR THAT WAS REPAIRED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW WAS CONDUCTED OF A CLINICAL ARTICLE THAT ASSESSED THE EFFECTIVENESS AND FEASIBILITY OF ROBOTIC PORTAL RESECTION (RPR) FOR MEDIASTINAL TUMORS AND THE FOLLOWING COMPLICATIONS WERE NOTED: (B)(4) PATIENTS WITH MEDIASTINAL TUMORS BETWEEN (B)(6) 2018 AND (B)(6) 2023 WERE ENROLLED IN THE STUDY. MOST PATIENTS WERE ASYMPTOMATIC ((B)(4)), AND NO MYASTHENIA GRAVIS WAS IDENTIFIED IN THE ENTIRE COHORT. ONE PATIENT EXPERIENCED AN INTRA-OPERATIVE LEFT INNOMINATE VEIN INJURY. THE INJURY WAS SUTURED USING A ROBOTIC PROCEDURE AND WITHOUT THE NEED FOR A CONVERSION TO THORACOTOMY. ALTHOUGH THE BLOOD LOSS DUE TO THE INJURY WAS NOT PROVIDED, IT WAS MENTIONED THAT THE MEDIAN BLOOD LOSS WAS 20 ML WITH THE RANGE OF 5.0¿30.0 ML FOR THE ENTIRE COHORT. (B)(4) PATIENTS UNDERWENT ACTIVE CONVERSION TO STERNOTOMY BECAUSE THE TUMORS WERE FOUND TO INVOLVE THE LEFT INNOMINATE VEIN DURING SURGERY. POSTOPERATIVE COMPLICATIONS WERE DEVELOPED IN (B)(4) PATIENTS, INCLUDING (B)(4) PATIENT WITH CHYLOTHORAX. THE POSTOPERATIVE CHYLOTHORAX WAS TREATED WITH CONSERVATIVE THERAPY (I.E. FASTING AND TOTAL PARENTERAL NUTRITION (TPN)) TO SUPPORT THE PATIENT. THE CHYLOTHORAX WAS RESOLVED AFTER 4 DAYS OF CARE. NO PERIOPERATIV

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW WAS CONDUCTED OF A CLINICAL ARTICLE THAT ASSESSED THE SAFETY AND FEASIBILITY OF MINIMALLY INVASIVE CYTOREDUCTIVE PROSTATECTOMIES (CRP) OF SINGLE-PORT (SP) OR MULTI-PORT (MP) ROBOTIC SYSTEMS, AND THE FOLLOWING COMPLICATIONS WERE MENTIONED. TWENTY-FOUR PATIENTS THAT UNDERWENT ROBOTIC-ASSISTED CRP IN ONE SINGLE INSTITUTION BETWEEN 2015 TO 2022 WERE ENROLLED IN THE STUDY. OF THE 24 MEN WITH A MEDIAN PROSTATE SPECIFIC ANTIGEN (PSA) OF 32 NG/ML WHO UNDERWENT CRP, 17 (71%) WERE DONE USING THE MP ROBOTIC SYSTEMS AND 7 (29%) WERE USING THE SP SYSTEMS. THE OVERALL MAJOR COMPLICATION RATE WAS 8%. IN THE MULTI-PORT GROUP, ONE PATIENT DEVELOPED A SMALL BOWEL OBSTRUCTION REQUIRING SURGICAL DECOMPRESSION (GRADE III), AND ANOTHER EXPERIENCED A LYMPHOCELE THAT REQUIRED PERCUTANEOUS INTERVENTION (GRADE III). TWO PATIENTS IN THE MULTI-PORT GROUP WERE REPORTED AS EXPERIENCING AN ANASTOMOTIC LEAK, BUT NO MEDICAL INTERVENTION NOR THE SEVERITY WERE PROVIDED IN THE ARTICLE. THERE WAS NO MENTION OF ANY DEVICE MALFUNCTIONS REPORTED DURING THE ROBOTIC ASSISTED SURGERIES IN THE ARTICLE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE AUTHORS, BUT NO RESPONSE HAS BEEN RECEIVED.

Monarch Platform — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT WHILE DRIVING IN THE RIGHT UPPER LOB (RUL), AND 25MM OUT FROM THE TARGET, USER DECIDED TO DO A SPIN TO CONFIRM HE WAS IN LINE WITH THE LESION AND GET READY TO PLACE A DYED COIL. THE SPIN WAS DONE AND THE SCOPE WAS OBSERVED TO BE THROUGH THE LUNG AND INTO THE PLEURAE WHILE THE SYSTEM WAS SHOWING THEY WERE 25MM OUT, RESULTING IN A PNEUMOTHORAX.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT DURING A PEDIATRIC SCOLIOSIS SURGERY, THE SURGEON PLANNED A T3-L2 SCAN AND PLAN WORKFLOW AND THE SURGEON EXPOSED T2-L3. AFTER EXPOSURE, THE SURGEON FREEHANDED THE LEFT L2 SCREW AND PLACED A FIDUCIAL MARKER IN LAMINA AT T10 (LAMINA IS A TECHNIQUE THE SURGEON USES TO HELP VERIFY ACCURACY). THE SPINOUS PROCESS CLAMP WAS ATTACHED ON THE SPINOUS PROCESS OF L2 AND CONNECTED THE SURGICAL ARM TO THE PATIENT WITH A STANDARD BRIDGE. THE AIRFRAME WAS PLACED WITH A DOUBLE SPINOUS PROCESS CLAMP AT T3 AND T4. A 3DEFINE SCAN SNAPSHOT WITH NAVIGATION AIRFRAME WAS THEN PERFORMED. THE STAR MARKER WAS PLACED AND A SUCCESSFUL IMAGING SPIN WAS TAKEN. THE SPIN WAS TRANSFERRED TO THE GUIDANCE SYSTEM VIA THUMB DRIVE. THE SURGEON ASSISTED WITH SCREW PLANNING ¿ IT WAS PLANNED AT T8-L1 ON THE LEFT SIDE (L2 WAS PLACED FREEHAND PRIOR) AND PLANNED T8-L2 ON THE RIGHT. THE SURGEON STARTED PLACING SCREWS ROBOTICALLY AT LEFT L1 AND WORKING CRANIALLY TO T8. THEY WERE PERIODICALLY CHECKING THE ROBOTIC AND NAVIGATION ACCURACY ON PATIENT'S ANATOMY, THE DIVOT ON THE ARM GUIDE, AND ROBOTICALLY BY SENDING

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: PHAM, M. H., HERNANDEZ, N. S., & STONE, L. E. (2024). PREOPERATIVE ROBOTICS PLANNING FACILITATES COMPLEX CONSTRUCT DESIGN IN ROBOT-ASSISTED MINIMALLY INVASIVE ADULT SPINAL DEFORMITY SURGERY¿A PRELIMINARY EXPERIENCE. JOURNAL OF CLINICAL MEDICINE, 13(7), 1829. HTTPS://DOI.ORG/10.3390/JCM13071829. BACKGROUND: THE CORRECTION OF ADULT SPINAL DEFORMITY (ASD) CAN REQUIRE LONG, COMPLEX CONSTRUCTS WITH MULTIPLE RODS WHICH TRAVERSE IMPORTANT BIOMECHANICAL LEVELS TO ACHIEVE MULTI-PELVIC FIXATION. MINIMALLY INVASIVE (MIS) PLACEMENT OF THESE CONSTRUCTS HAS HISTORICALLY BEEN DIFFICULT. ADVANCED TECHNOLOGIES SUCH AS SPINAL ROBOTICS PLATFORMS CAN FACILITATE THE DESIGN AND PLACEMENT OF THESE CONSTRUCTS AND FURTHER ENABLE THESE SURGICAL APPROACHES IN MIS DEFORMITY SURGERY. METHODS: A RETROSPECTIVE STUDY WAS PERFORMED ON A SERIES OF ASD PATIENTS UNDERGOING MIS DEFORMITY CORRECTION WITH =EIGHT FUSION LEVELS TO THE LOWER THORACIC SPINE WITH PREOPERATIVE ROBOTIC CONSTRUCT PLANNING AND ROBOT-ASSISTED PEDICLE SCREW PLACEMENT. RESULTS: THERE WERE 12 PATIENTS (10 FEMALE, MEAN AGE 68.6 YEARS) WITH A DIAGNOSIS OF EITHER DEGENERATIVE SCOLIOSIS (8 PATIENTS) OR SAGITTAL IMBALANCE (4 PATIENTS). ALL UNDERWENT PREO

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT ¿INCORRECT CUTS WERE MADE¿ WHILE USING THE ROBOTIC-ASSISTED SOLUTION SATELLITE STATION DEVICE. ACCORDING TO THE REPORT, THE SURGEON INITIALLY CUT FOR A SIZE 6 FEMUR AND WANTED TO RECUT TO A SIZE 5 FEMUR TO OPEN FLEXION SPACE. THE REPORTER STATED THAT THE ROBOT WAS SET TO ¿ANTERIOR REFERENCING¿, SO THE SURGEON CHANGED TO A SIZE 5 AND RECUT FEMUR. IT WAS REPORTED THAT THE CUTS WERE OFF BY OVER ¿ONE FULL SIZE AND THE CHAMFER CUTS WERE ANGLED WAY OFF.¿ THE REPORTER STATED THAT THE SURGEON DID NOT OBSERVE PIN OR ARRAY MOVEMENT, BUT IT COULD HAVE HAPPENED. THE SURGEON SWITCHED FROM PRESS FIT TO CEMENTED CRS REVISION FEMUR WITH 30MM STEM AND A RP REVISION TIBIA WITH A CONSTRAINED CRS FEMUR DUE TO CUTS NOT MATCHING. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT STARTED WITH 15 DEGREES OF FLEXION CONTRACTURE. AFTER THE INITIAL CUTS, THE PATIENT HYPER EXTENDED BY 15 DEGREES AND WAS ANOTHER REASON TO USE CRS REVISION COMPONENTS. IT WAS REPORTED THAT THERE WAS A SURGICAL DELAY OF 35 MINS. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BE

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE DOCTOR WAS DOING AN INTRA-OP ROBOT CASE AT LEVELS L3-L5. WE PLACED SCREWS ON THE RIGHT SIDE FOLLOWED BY THE LEFT. WE ALSO DID A CHECK WITH THE VERIFICATION PROBE TO ENSURE TRAJECTORY AND CONFIRMATION OF SCREWS. EVERYTHING LOOKED GOOD THUS FAR. AFTER THE PLACEMENT OF SCREWS AND RODS, WE PROCEEDED TO TAKE A 2ND SPIN TO CONFIRM SCREW AND ROD PLACEMENTS. WE THEN DISCOVERED THE SCREW AT L4R HAD SHIFTED A BIT LATERAL OF THE PEDICLE.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: EGPS PERFORMED A CASE PERFECTLY TODAY THEN WAS POWERED DOWN. 45 MINUTES LATER IT WAS POWERED BACK UP TO LOAD A SCAN BUT WOULD NOT POWER UP. BATTERY LIGHT WAS CYCLING ,YELLOW INFORMATION RING WAS ON, NO SYNC MONITOR WARNING COMES UP BUT NOTHING APPEARED ON THE SCREEN. WE HAVE REBOOTED MULTIPLE TIMES CHANGED POWER SUPPLY POINT MULTIPLE TIME AND FRANCESCO BELIEVES IT TO BE A COMPUTER FAILURE AND THAT THE COMPUTER NEEDS TO BE REPLACED.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT SCREWS USING THE EXCELSIUS GPS SYSTEM WERE MISPLACED INTRA-OPERATIVELY AND THEN REMOVED AND REPLACED.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WAS AN ALLEGED SCREW DEVIATION IN A SCAN AND PLAN CASE. THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE PATIENT WAS HAVING MULTIPLE SCREWS PLACED FROM THE THORACIC TO THE LUMBAR VERTEBRAE FOR A SCOLIOSIS PROCEDURE. THE REP REPORTED THAT MULTIPLE ACCURACY CHECKS WERE PERFORMED, HOWEVER, WHEN T4 ON THE RIGHT SIDE WAS DRILLED, THE PATIENT'S MOTOR WAS TESTED AND WAS ABSENT. WHEN A POST SURGICAL SCAN WAS PERFORMED, THE SCREW PLACED IN T5 WAS POTENTIALLY DEVIATED BY 1-2 MILLIMETERS (MM), BUT PER THE REP, THE SURGEON BELIEVED THAT THE T4 DRILL WAS ACCURATE AND THAT THE PEDICLE FRACTURED ON THE RIGHT SIDE. ALL OTHER SCREWS PLACED IN THE LEFT AND RIGHT VERTEBRAE APPEARED ACCURATE IN THE SOFTWARE. THERE WAS NO SURGICAL DELAY TIME AND THE PATIENT WAS AFFECTED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ROBOTIC MEGA SUTURE CUT NEEDLE DRIVER'S WIRES BROKE WHILE INSIDE PATIENT. SURGEON AWARE. NO VISIBLE SIGNS OF ANY PIECES LEFT INSIDE PATIENT. INSTRUMENT REMOVED FROM SERVICE AND GIVEN TO RISK MANAGER.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A REVIEW OF A LITERATURE ARTICLE DESCRIBING A RETROSPECTIVE ANALYSIS OF ALL PATIENTS UNDERGOING DA VINCI-ASSISTED ROBOTIC DISTAL PANCREATECTOMY (DP) AND PANCREATICODUODENECTOMY (PD) PROCEDURES PERFORMED BY A SINGLE SURGEON, WAS COMPLETED. THE STUDY EVALUATED THE SAFETY AND FEASIBILITY OF INSTITUTING A ROBOTIC PANCREATECTOMY PROGRAM. THE STUDY INCLUDED SURGERIES FROM MAY 2014 TO DECEMBER 2020, DURING WHICH 62 PATIENTS UNDERWENT ROBOTIC PANCREATECTOMY, 34 PATIENTS WERE IN THE PD GROUP AND 28 PATIENTS WERE IN DP GROUP. 13 PATIENTS REQUIRED CONVERSION TO OPEN SURGERY IN PD GROUP DUE TO VEIN RESECTION, BILIOPANCREATIC RESECTION OR DIFFICULT DISSECTION. POST-OPERATIVELY, IN THE PANCREATICODUODENECTOMY (PD) GROUP, NINE PATIENTS (26.5%) EXPERIENCED CLAVIEN-DINDO GRADE III OR MORE COMPLICATIONS COMPARED TO 5 PATIENTS (17.9%) IN THE DISTAL PANCREATECTOMY (DP) GROUP. OF THE 5 GRADE B/C POSTOPERATIVE PANCREATIC FISTULA (POPF) IN THE PD GROUP, 4 PATIENTS REQUIRED OPERATIVE INTERVENTION WHILST ALL OF THOSE IN THE DP GROUP WERE MANAGED EITHER ENDOSCOPICALLY OR WITH PROLONGED USE OF SURGICAL DRAINS. THREE PATIENTS EXPERIENCED POST-PANCREATECTOMY HEMORRHAGE IN PD GROUP WHILE 1 PATIENT IN DP GROUP.

ExcelsiusGPS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: THE SURGEON USED THE NS INSTRUMENTATION TO MARK PLACEMENT OF THE BURR HOLES. THE PATIENT AND EGPS WERE DRAPED AND THE IGEE WAS VERIFIED BY THE SCRUB TECH. THE EGPS WAS PUSHED IN WITH THE O-ARM STILL IN SCAN POSITION TO ALLOW FOR EVALUATION SHOTS. ONCE THE INCISION/APPROACH WAS COMPLETED, THE ARM WAS BROUGHT IN ALONG THE VIM R TRAJECTORY. AS THE SURGEON PLACED THE CANNULA IN THE CENTRAL TRAJECTORY, THE ENTRY POINT APPEARED TO BE CLOSE TO THE POSTERIOR EDGE OF THE BURR HOLE COVER. AS THE SURGEON INSERTED THE CANNULA, HE BOVIED THE CANNULA WHICH CAUSED THE EGPS SCREEN TO TEMPORARILY BLACK OUT DURING THE BOVIE USAGE WHEN THE CANNULA WAS SEATED, AN O-ARM SPIN WAS PERFORMED TO CHECK CANNULA PLACEMENT. THE CANNULA TRAJECTORY WAS OFF WITH THE ENTRY POINT POSTERIOR AND THE TRAJECTORY POINTING ANTERIOR. THE TIP OF THE CANNULA (PLANNED FOR 10MM ABOVE TARGET) PRESENTED A DEVIATION OF E/ 11.5 AND E/1.4. LANDMARK CHECKS WERE PERFORMED AGAIN AND IT APPEARED THAT THE CENTER OF THE BURR HOLE SHOWED ANTERIOR OF THE PLANNED TRAJECTORY ON THE SCREEN. A STERILE REGISTRATION WAS THEN PERFORMED BUT FOLLOWING THE TRANSFER OF THE SPIN AND CONFIRMATION OF THE FIDUCIALS, THE EGPS PRESENTED AN ERROR STATING T

VELYS — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: IT WAS REPORTED THAT DURING A TOTAL KNEE ARTHROPLASTY SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHILE USING THE ROBOTIC-ASSISTED SOLUTION SATELLITE STATION DEVICE THE MEDICAL CRUCIATE LIGAMENT WAS UNINTENTIONALLY CUT. IT WAS REPORTED THAT REVISION COMPONENTRY WAS REQUIRED. THE LIGAMENT WAS REPAIRED AND IMPLANTED COMPONENTS LOOKED GOOD. IT WAS REPORTED BY THE SURGEON THAT THE RETRACTORS SHOULD HAVE BEEN PLACED BETTER. IT WAS REPORTED THAT THE DEVICE WAS BEING USED WITH A ROBOTIC ASSISTED BASE STATION DEVICE. THERE WERE NO DELAYS IN THE PROCEDURE REPORTED. THERE WAS PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A STUDY TO EVALUATE THE ONCOLOGICAL OUTCOMES POST TRANSORAL ROBOTIC SURGERY (TORS) FOR HUMAN PAPILLOMAVIRUS (HPV)-ASSOCIATED OROPHARYNGEAL SQUAMOUS CELL CARCINOMA, WAS SUMMARIZED IN A LITERATURE ARTICLE DESCRIBING A RETROSPECTIVE ANALYSIS ON 184 PATIENTS THAT UNDERWENT DA VINCI-ASSISTED TRANSORAL ROBOTIC SURGERY (TORS) WITH NECK DISSECTION IN ONE SINGLE INSTITUTION PERFORMED BY TWO TRAINED SURGEONS. POST-OPERATIVE TORS-RELATED COMPLICATIONS OCCURRED IN 12 PATIENTS (6.5%). NINE PATIENTS (4.9%) HAD A SECONDARY POST-OPERATIVE BLEED, DEFINED AS BLEEDING OCCURRING GREATER THAN 24 HOURS FOLLOWING SURGERY, WITH ALL PATIENTS BEING SUCCESSFULLY MANAGED EITHER CONSERVATIVELY OR WITH OPERATIVE MANAGEMENT. SALIVARY FISTULA OCCURRED IN 2 PATIENTS (1.1%). PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) INSERTION FOR SWALLOWING DYSFUNCTION OCCURRED IN 10 PATIENTS (5.4%) WITH ONLY 2 PATIENTS (1.1%) REQUIRING FOR GREATER THAN 12 MONTHS. THERE WERE NO DA VINCI DEVICE ISSUES REPORTED IN THE ARTICLE. ATTEMPTS WERE MADE TO CONTACT THE ARTICLE AUTHOR, BUT NO RESPONSE HAS BEEN RECEIVED.

da Vinci Surgical System — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.